A Phase 3 Evaluation of Sutacimig in Glanzmann Thrombasthenia
Key facts
- Who runs it
- Hemab ApS
- Where
- Durham, Houston, Indianapolis, La Jolla, Los Angeles, Minneapolis, New York, Sacramento, and San Francisco, United StatesSee the 9 sites
- Trial code
- NCT07935356
- U1111-1342-3293
- Status
- Recruiting
- Phase
- Phase 3
- People taking part
- 76 people, planned
- Started
- 27 Oct 2026
- Expected to end
- Jan 2030
- Type of study
- Interventional
- Treatments tested
- Sutacimig
- Record updated
- 13 November 2026
Who can take part
- Age
- 12 years to 70 years
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
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Who can take part
- Has the ability to provide informed consent to participate in the clinical study before completing any study-related procedures, and has an understanding, ability, and willingness to comply with clinical study procedures and restrictions
- Adults 18 to 70 years
- Adolescents 12 to <18 years, dependent on geographical location
- Has clinical bleeding phenotype consistent with Glanzmann thrombasthenia (GT) and documentation of either diagnostic laboratory criteria (a) or (b) below:; Abnormal platelet aggregometry AND flow cytometry; A confirmed genetic mutation in ITGA2B or ITGB3
- Participants have experienced at least four treated bleeding events related to GT within the 12 months prior to Screening
Who cannot take part
- Prior exposure to sutacimig
- History of clinically significant hypersensitivity associated with monoclonal antibody therapies
- Congenital or acquired bleeding disorders other than GT
- Medical condition (other than GT) that constitutes an increased risk of having uncontrolled bleeding events during the study or other conditions per Investigator discretion
- History of venous or arterial thromboembolic (TE) event or TE disease except for catheter-associated vein thrombosis
- Co-existing thrombophilia disorder
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 12 and 70 years old?
Where in United States
- Science 37Durham, United StatesContact: Clinical TrialsTaking people
- Gulf States Hemophilia and Thrombophilia Center - Texas Medical CenterHouston, United StatesContact: Clinical TrialsTaking people
- Innovative Hematology - Indiana Hemophilia & Thrombosis CenterIndianapolis, United StatesContact: Clinical TrialsTaking people
- University of California San Diego (UC San Diego) Health - Jacobs Medical CenterLa Jolla, United StatesContact: Clinical TrialsTaking people
- Children's Hospital Los AngelesLos Angeles, United StatesContact: Clinical TrialsTaking people
- M Health Fairview University of Minnesota Medical CenterMinneapolis, United StatesContact: Clinical TrialsTaking people
- New York - Presbyterian - Weill Cornell Medical CenterNew York, United StatesContact: Clinical TrialsTaking people
- University of California Davis (UC Davis) Medical CenterSacramento, United StatesContact: Clinical TrialsTaking people
- University of California San Francisco - UCSF Medical CenterSan Francisco, United StatesContact: Clinical TrialsTaking people
About the trial
What the trial wants to find out
Glanzmann thrombasthenia (GT) is a serious inherited bleeding disorder. In GT, platelets, the blood cells that normally stick together at the site of an injury to stop bleeding, are unable to properly do so. As a result, bleeding does not stop as it should. Bleeding in GT often starts without warning, can happen frequently, and can be severe. It most commonly affects the nose, mouth and gums, gastrointestinal tract, and skin, and many women and girls with GT experience heavy menstrual bleeding. Over time, bleeding can lead to iron deficiency and anemia. Some bleeding episodes require emergency care, hospitalization, transfusion, or surgery, and some can be life-threatening.
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Sutacimig is an investigational medicine given as an injection under the skin (subcutaneous injection). It is designed to help platelets work at the site of bleeding despite the underlying defect in GT. It is intended to be given regularly to help prevent bleeding (prophylaxis), rather than only to treat bleeding after it starts.
The purpose of this study is to find out whether sutacimig, given as prophylaxis, reduces the number of treated bleeding episodes in people with GT compared with no prophylaxis, and to evaluate its safety and tolerability.
The group in the trial
- SutacimigTreatment being tested
Participants will receive sutacimig 0.2 milligrams per kilogram (mg/kg) by subcutaneous injection once weekly for 48 weeks. Upon completion of the 48-week treatment period, participants will be offered the opportunity to transition to a separate open-label extension (OLE) study for continued assessment of the prophylactic treatment with sutacimig.
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- SOLARA: A Phase 3 Study of the Efficacy and Safety of Sutacimig in Participants With Glanzmann Thrombasthenia
- Fit questions
- Built from NCT07935356, who can take part
- Record updated
- 13 November 2026